MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER; NRY

Model Number RED68KIT-R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 02/03/2022

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system red 68 reperfusion catheter (red68), a non-penumbra microcatheter, and a non-penumbra guide catheter.During the procedure, it was reported that a dissection had occurred in cavernous segment of the internal carotid artery (ica).No additional information is available.

Manufacturer Narrative

From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the penumbra system include, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, vessel spasm, thrombosis, dissection, including death.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 13816683
• MDR Text Key: 288806987
• Report Number: 3005168196-2022-00127
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948024113
• UDI-Public: 00815948024113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RED68KIT-R
• Device Catalogue Number: RED68KIT
• Device Lot Number: H11700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male